1. Field of the Invention
This invention relates to the sealing of a vascular puncture site. In particular, this invention relates to an apparatus for rapidly sealing an arterial puncture site using a naturally occurring sealant (e.g., a patient specific fibrin glue).
2. Background Art
Approximately 50 years ago, the Seldinger Technique of percutaneous entry into a vascular structure by use of a needle and a guidewire technique was introduced to modern medicine and subsequently has become the standard in the medical industry. Prior to Seldinger's discovery of entry into vascular structures, procedures required an incision through the skin and tissues, followed by an incision into the artery wall.
This earlier technique had numerous problems associated with it, i.e., infection, uncontrolled bleeding, trauma to the tissue and vessel wall. Thus, the advent of Seldinger's Technique was widely and rapidly accepted by the medical profession, and it became the world standard due to its advantages to both patient and doctor. The patient benefitted by less trauma, reduced risk of uncontrolled bleeding and vessel clotting, along with greatly reduced risk to infection. Doctors benefitted by the ease of entry and exit in the procedure.
Seldinger's Technique does not require suturing the artery puncture site or the skin and adjacent tissue as earlier procedures had required. Over the past 50 years, Seldinger's Technique has remained virtually unchanged, its many advantages far outweigh the main disadvantage--namely, the sealing of the arterial puncture site. Using Seldinger's Technique, in order to seal the arterial puncture site, it is necessary to apply strong pressure to compress the arterial wall sufficiently to reduce blood flow and intraluminal pressure to allow initiation of the body's own hemostatic processes. Typically, compression takes between 45 minutes to one hour before closure of the arteriotomy by natural clotting. Following this, inactivity with bed rest is required for eight to twelve hours to allow the clot to strengthen. The patient often cannot return to normal activity for up to two to three days following an arteriotomy procedure.
The medical, social, and economic impact of this prolonged recovery period is considerable. In fact, with over three million arteriotomy procedures annually in just the United States, the prolonged recovery period of the Seldinger technique has an economic impact of billions of dollars through an additional day's stay in hospital costs alone. Therefore, a need exists to develop a safe and effective means for sealing the arterial wall following arteriotomy procedures that allows the patient to quickly return to normal activity.
Additionally, other efforts have been attempted to solve the problem of sealing the arteriotomy site. For example, there is a current project underway using a foreign material (i.e., bovine collagen) to plug the arteriotomy site. These devices, however, rely on a non-removable biodegradable anchoring member to position the plug at the arteriotomy site. This anchoring member remains within the intraluminal space. The delayed biodegradation of the plug and its anchor can cause thrombus formation at the arteriotomy site.
Moreover, the FDA's current position on bovine collagen for use in plastic surgery (i.e., it hits been withdrawn pending further investigation) indicates an unlikeliness of these devices and foreign body plugs gaining medical and governmental acceptance. Therefore, there still exists a need for a safe and biocompatible agent and method for sealing an arteriotomy site.